RHB-2041 is a next-generation optimized formulation of RedHill's oral RHB-1042, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking Mycobacterium avium subspecies paratuberculosis (MAP)-targeted therapeutic approach for Crohn's disease (CD)

In its positive Phase 3 study, RHB-104 met the primary and key secondary endpoints with statistical significance, showing RHB-104 plus standard of care (SoC) to be 64% more effective than SoC alone, in treating CD compared to the placebo (standard of care only) group (p = 0.0048)3

New RHB-204 in vitro data, from both spot and phage assays, demonstrated comparable MAP killing to RHB-1044. Importantly, MAP killing efficacy was achieved with lower doses of two of the active ingredients compared to RHB-104, indicative of potential for reduced toxicity and side effects

Based on the FDA guidance on path to approval, RedHill's novel Phase 2 RHB-204 study is designed to be the first-ever adequately controlled clinical study in a specifically defined MAP-positive CD patient population - a potentially paradigm changing approach to treatment of Crohn's disease. With discussions ongoing and grant application submitted, funding for this program is planned to be non-dilutive 

Expected transferal of RHB-104's FDA pediatric orphan drug designation to RHB-204, potential for breakthrough therapy designation, fast track designation, additional regulatory exclusivity and priority review voucher. RHB-204 is patent protected through 2041, granted FDA Fast Track and Orphan Drug Designation, QIDP Designation under the GAIN Act (extending US market exclusivity to a potential total of 12 years) and EU Orphan Designation (eligibility for 10 years EU market exclusivity) for NTM disease caused by MAC5

The multibillion-dollar CD market is expected to grow from $13.6 billion in 2024 to over $19 billion in 2033 in key markets,6 presenting a significant opportunity for new FDA-approved therapies

RALEIGH, N.C. and TEL AVIV, Israel, April 30, 2026 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced new in vitro testing results demonstrating RHB-204's comparability to RHB-104 in Mycobacterium avium subspecies paratuberculosis (MAP) killing efficacy. Oral RHB-204 is a next-generation optimized formulation of RedHill's RHB-104, designed for enhanced tolerability, safety profile and patient adherence, that employs a groundbreaking MAP-targeted therapeutic approach to the treatment of Crohn's disease (CD).